A Biosample Operations Manager Support job located in Whippany, NJ is currently available through Belcan. The Biosample Operations Manager plans and coordinates all operational activities for the collection, handling, storage and delivery of biomarker, pharmacogenetic, immunogenicity and pharmacokinetic samples (in following: biosamples) within Phase I to III clinical study, while being simultaneously assigned to multiple studies
Biosample Operations Manager Support job duties:
Plans, organizes, monitors and enforces the collection, processing, storage and logistics of Biosamples within a study
Accountable for preparation of study related documents (biosample management plan, laboratory manual, sample handling sheets etc.) as well as development of shipment schedules, sampling and storage requirements in close collaboration with central and analytical laboratories
Responsible for handling of samples according to protocol, SOPs, GCP and ICH-guidelines.
For Phase 1 studies, initiates the contracts with the biosample management central laboratory and will be responsible to support the forecasting of the cost and tracking the budget of these contracts in the respective studies
Training of monitors, study nurses and investigators
Supports the study team with the submission to IRBs and ECs and responds to IRB/EC requests
Responsible for the tracking, monitoring and documentation of biosampling activities
Post-graduate degree in Life Sciences (MSc, PhD)
3 years experience in clinical research, with detailed understanding of clinical development processes (e.g. study management or CRA)
Detailed knowledge of the ethical, legal and logistic requirements of obtaining and processing human blood and tissue samples
Proven clinical development experience of working in teams running clinical studies (study management), monitoring clinical studies or experience of working in clinical studies at an investigator site
Good knowledge of BM and PK analytical processes
Proven ability to plan, organize and manage multiple projects under pressure
Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
Effective communication and negotiation skills in English
0-5%, depending on projects needs
If you are interested in this Biosample Operations Manager job in Whippany, NJ, please apply via the apply now link provided.
Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services - from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.
Associated topics: cultivate, fertilize, fork lift, garden, inventory, manage, management, plant management, prune, ship